The device maker failed to supply to FDA information about a two-year-old recall of the main control board in specific lots of the company’s InnerCool RTx endovascular system.
By Jim Dickinson
FDA’s Los Angeles district office in December issued a warning letter to Philips Healthcare for failing to supply to the agency information about a two-year-old recall of the main control board in specific lots of the company’s InnerCool RTx endovascular system. The violation was found during an FDA inspection of the company’s San Diego, CA, manufacturing facility in July 2013.
The letter says the control board was recalled on the specified devices due to reports of low temperature readings that could cause the console to deliver additional heat energy to patients.
The firm’s response in August was inadequate, FDA wrote, and the company was told to contact the district office recall coordinators to provide the appropriate information for all corrections and removals that have been conducted.
Philips was told to take immediate action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of KIBSRI/FREEDIGITALPHOTOS.NET]